FDA 510(k)

Renuvion® Micro Handpiece

Número K: K230586 · 2023-06-09

Data da decisão2023-06-09

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Renuvion® Micro Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230586. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Renuvion® Micro Handpiece?

Renuvion® Micro Handpiece is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Apyx Medical Corporation. The 510(k) number is K230586.

When did Renuvion® Micro Handpiece receive FDA 510(k) clearance?

Renuvion® Micro Handpiece received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230586.

Who is the listed applicant for Renuvion® Micro Handpiece?

The FDA 510(k) record lists Apyx Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renuvion® Micro Handpiece?

The FDA product code for Renuvion® Micro Handpiece is GEI.

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Fonte oficial

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